Is a randomized controlled trial of waterbirth possible? An Australian feasibility study.
childbirth
cohort study
feasibility
midwifery
waterbirth
Journal
Birth (Berkeley, Calif.)
ISSN: 1523-536X
Titre abrégé: Birth
Pays: United States
ID NLM: 8302042
Informations de publication
Date de publication:
12 2022
12 2022
Historique:
revised:
15
02
2022
received:
23
09
2020
accepted:
08
03
2022
pubmed:
5
4
2022
medline:
11
11
2022
entrez:
4
4
2022
Statut:
ppublish
Résumé
The safety of waterbirth is contested because of the lack of evidence from randomized trials and conflicting results. This research assessed the feasibility of a prospective study of waterbirth (trial or cohort). We conducted a prospective cohort study at an Australian maternity hospital. Eligible women with uncomplicated pregnancies at 36 weeks of gestation were recruited and surveyed about their willingness for randomization. The primary midwife assessed waterbirth eligibility and intention on admission in labor, and onset of second stage. Primary outcomes measured feasibility. Intention-to-treat analysis, and per-protocol analysis, compared clinical outcomes of women and their babies who intended waterbirth and nonwaterbirth at onset of second stage. 1260 participants were recruited; 15% (n = 188) agreed to randomization in a future trial. 550 women were analyzed by intention-to-treat analysis: 351 (waterbirth) and 199 (nonwaterbirth). In per-protocol analysis, 14% (n = 48) were excluded. Women in the waterbirth group were less likely to have amniotomy and more likely to have water immersion and physiological third stage. There were no differences in other measures of maternal morbidity. There were no significant differences between groups for serious neonatal morbidity; four cord avulsions occurred in the waterbirth group with none in the landbirth group. An RCT would need approximately 6000 women to be approached at onset of second stage. A randomized trial of waterbirth compared with nonwaterbirth, powered to detect a difference in serious neonatal morbidity, is unlikely to be feasible. A powered prospective study with intention-to-treat analysis at onset of second stage is feasible.
Sections du résumé
BACKGROUND
The safety of waterbirth is contested because of the lack of evidence from randomized trials and conflicting results. This research assessed the feasibility of a prospective study of waterbirth (trial or cohort).
METHODS
We conducted a prospective cohort study at an Australian maternity hospital. Eligible women with uncomplicated pregnancies at 36 weeks of gestation were recruited and surveyed about their willingness for randomization. The primary midwife assessed waterbirth eligibility and intention on admission in labor, and onset of second stage. Primary outcomes measured feasibility. Intention-to-treat analysis, and per-protocol analysis, compared clinical outcomes of women and their babies who intended waterbirth and nonwaterbirth at onset of second stage.
RESULTS
1260 participants were recruited; 15% (n = 188) agreed to randomization in a future trial. 550 women were analyzed by intention-to-treat analysis: 351 (waterbirth) and 199 (nonwaterbirth). In per-protocol analysis, 14% (n = 48) were excluded. Women in the waterbirth group were less likely to have amniotomy and more likely to have water immersion and physiological third stage. There were no differences in other measures of maternal morbidity. There were no significant differences between groups for serious neonatal morbidity; four cord avulsions occurred in the waterbirth group with none in the landbirth group. An RCT would need approximately 6000 women to be approached at onset of second stage.
CONCLUSIONS
A randomized trial of waterbirth compared with nonwaterbirth, powered to detect a difference in serious neonatal morbidity, is unlikely to be feasible. A powered prospective study with intention-to-treat analysis at onset of second stage is feasible.
Identifiants
pubmed: 35373861
doi: 10.1111/birt.12635
pmc: PMC9790445
doi:
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
697-708Informations de copyright
© 2022 The Authors. Birth published by Wiley Periodicals LLC.
Références
Women Birth. 2011 Dec;24(4):165-72
pubmed: 21167799
N Engl J Med. 2017 Oct 5;377(14):1391-1398
pubmed: 28976864
BMJ. 1994 Oct 22;309(6961):1089
pubmed: 7950767
Obstet Gynecol. 2021 Oct 1;138(4):622-626
pubmed: 34623074
Am J Epidemiol. 2019 Sep 1;188(9):1695-1704
pubmed: 31145428
Midwifery. 2018 Jul;62:240-255
pubmed: 29727829
J Clin Microbiol. 2003 May;41(5):2227-9
pubmed: 12734286
J Womens Health (Larchmt). 2021 May;30(5):681-688
pubmed: 32907460
Pediatrics. 2002 Aug;110(2 Pt 1):411-3
pubmed: 12165605
Obstet Gynecol. 2020 Oct;136(4):707-715
pubmed: 32925614
BMJ. 2010 Feb 05;340:c221
pubmed: 20139215
J Obstet Gynaecol Can. 2020 Feb;42(2):150-155
pubmed: 31843289
Aust N Z J Obstet Gynaecol. 2018 Oct;58(5):539-547
pubmed: 29344940
Epidemiology. 2017 Jan;28(1):54-59
pubmed: 27748683
Birth. 2012 Sep;39(3):192-202
pubmed: 23281901
Midwifery. 2013 Jul;29(7):759-64
pubmed: 22884894
Am J Obstet Gynecol. 2004 May;190(5):1211-5
pubmed: 15167820
Eur J Obstet Gynecol Reprod Biol. 2000 Jul;91(1):15-20
pubmed: 10817872
J Matern Fetal Neonatal Med. 2005 May;17(5):357-61
pubmed: 16147851
Pediatrics. 2014 Apr;133(4):758-61
pubmed: 24652300
J Midwifery Womens Health. 2020 Mar;65(2):216-223
pubmed: 31489975
Eur J Obstet Gynecol Reprod Biol. 2011 Mar;155(1):27-30
pubmed: 21185644
J Midwifery Womens Health. 2016 Jan-Feb;61(1):11-20
pubmed: 26789485
Int J Evid Based Healthc. 2007 Sep;5(3):360-4
pubmed: 21631797
Birth. 2022 Dec;49(4):697-708
pubmed: 35373861
PLoS Med. 2012;9(3):e1001192
pubmed: 22427749
BMC Pregnancy Childbirth. 2021 Mar 26;21(1):256
pubmed: 33771115
BMC Pregnancy Childbirth. 2013 Mar 07;13:59
pubmed: 23497085
Trials. 2006 May 11;7:13
pubmed: 16689989
BMJ. 1999 Aug 21;319(7208):483-7
pubmed: 10454400
Cochrane Database Syst Rev. 2018 May 16;5:CD000111
pubmed: 29768662
Taiwan J Obstet Gynecol. 2016 Jun;55(3):363-7
pubmed: 27343316
Birth. 2018 Dec;45(4):416-423
pubmed: 29900579
J Perinat Neonatal Nurs. 2020 Jan/Mar;34(1):16-26
pubmed: 31834005
Birth. 2005 Mar;32(1):60-6
pubmed: 15725206
J Perinat Med. 2004;32(4):308-14
pubmed: 15346814
BMC Pregnancy Childbirth. 2014 Jan 14;14:17
pubmed: 24423216
J Obstet Gynaecol Can. 2019 Jun;41(6):805-812
pubmed: 30904342
Midwifery. 2019 Dec;79:102554
pubmed: 31610360
Syst Rev. 2014 May 29;3:55
pubmed: 24886615
Midwifery. 2018 Apr;59:27-38
pubmed: 29353689
BMC Med Res Methodol. 2015 Oct 15;15:87
pubmed: 26472109
Midwifery. 2019 Dec;79:102547
pubmed: 31610362
Women Birth. 2020 Nov;33(6):566-573
pubmed: 31883699
BMJ. 1995 Aug 5;311(7001):390-1
pubmed: 7640561
Eur J Obstet Gynecol Reprod Biol. 2007 Sep;134(1):37-43
pubmed: 17092628
JAMA. 2021 Aug 3;326(5):433-434
pubmed: 34342631
BJOG. 2022 May;129(6):950-958
pubmed: 34773367